Events

Recall of Pressure Care Medical Mattresses and Mattress Covers

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Australian Comfort Group.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01408-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01408-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    An issue has been identified where defective labels on the printed mattress covers at the foot of the mattress may let liquid through the cover material into the foam mattress and may produce a very low risk of contamination of the mattress. the risk of infection from this defective label to a patient is very small and very unlikely.
  • Action
    The Comfort Group is advising customers to quarantine affected stock. Collection of affected products and replacement with unaffected goods will take place as soon as possible.

Device

Pressure Care Medical Mattresses and Mattress Covers
  • Model / Serial
    Pressure Care Medical Mattresses and Mattress CoversNP200 Mattress Cover onlyNP200W90E Pressure Care MattressNP200W90NE Pressure Care MattressManufactured between 01 June 2014 and 31 January 2016ARTG Numbers: 261172, 260051
  • Manufacturer
    Australian Comfort Group

Manufacturer

Australian Comfort Group